A Breast Cancer Information Registry for Participants With Breast Cancer or Characteristics of Hereditary Breast Cancer

OBJECTIVES:

- To develop a web-based Breast Cancer Collaborative Registry (BCCR) as a repository for
socio-demographic, environmental, clinical history, family history, and biospecimen
data collected at the National Comprehensive Cancer Network (NCCN) centers for
participants with a personal history of breast cancer and/or characteristics of
hereditary breast cancer.

- To merge the data already being collected on breast cancer patients under the Adult
Oncology Data Collection Study and newly diagnosed breast cancer patients participating
in the NCCN Data Coordinating study at UNMC/NMC.

- To standardize clinical, environmental, socio-demographic, and family history data for
breast cancer-related information to be collected and shared for research purposes by
Eppley Breast Cancer Research Group breast cancer research collaborators.

- To collect, validate, and disseminate the breast cancer-related data to establish a
high-risk cohort for future research into the molecular and biological bases of breast
cancer susceptibility and interventional trials.

OUTLINE: This is a multicenter study.

Study participants undergo data collection related to breast cancer studies at one of the
National Comprehensive Cancer Network (NCCN) centers for inclusion in the Breast Cancer
Collaborative Registry (BCCR). The BCCR is a comprehensive computerized database that serves
as a repository for socio-demographic, environmental, clinical history, family history, and
biospecimen data collected for breast cancer patients treated on UNMC protocols. Central
features of the registry include standardized data-entry forms and a relational database
that can be used as a resource for the study of the pathology, immunology, cytogenetics,
molecular biology, epidemiology, clinical features, and outcome of patients with benign,
pre-malignant, or malignant breast disease.

Study participants complete a self-administered electronic or paper-based survey and a
medical history questionnaire at baseline to provide information on demographics (e.g., age
and sex); personal and family medical history; treatment history; lifestyle, physical
activity, and dietary habits; quality of life; environmental exposure history; and the
family tree for inclusion in the registry. Participants also undergo telephone or in-person
structured interviews conducted by study coordinators, genetic counselors, or the System
Coordinator of the BCCR to provide additional information or clarification of the
information provided in the questionnaires.

Study participants also undergo review of their medical records and pathology reports to
obtain detailed medical and treatment-related information for inclusion in the registry. The
information collected includes retrospective and prospective disease-specific data (e.g.,
diagnosis, grade/stage, and laboratory values) and longitudinal outcome data (e.g., response
to treatment, toxicity, survival, relapse) derived during prospective clinical follow-up.

Study participants are followed periodically to update relevant health and family histories.

DISEASE CHARACTERISTICS:

- Recruited by a participating physician and meets at least 1 of the following
criteria:

- Current diagnosis or history of breast cancer, atypical hyperplasia, ductal
carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) as defined in the
National Comprehensive Cancer Network Breast and/or Ovarian Genetic Assessment
Guidelines, v.1.2006

- Characteristics of hereditary breast cancer, as defined in the National
Comprehensive Cancer Network Breast and/or Ovarian Genetic Assessment
Guidelines, v.1.2006 (relatives have been diagnosed with breast and/or ovarian
cancer) OR have a breast cancer risk of > 1.67% over 5 years as estimated by the
GAIL Model

- Hormone receptor status not specified

PATIENT CHARACTERISTICS:

- Male or female

- Menopausal status not specified

PRIOR CONCURRENT THERAPY:

- Not specified